The guidelines for storage of drugs are not being properly followed by manufacturers, distributors and retailers across the country leading to deterioration of the quality of medicines available in the market, sources in the Union health ministry has said.
According to the sources, the ministry in its reply to a Committee on Subordinate Legislation over a representation on the issue, said that starting from drug manufacturing companies to distributors and chemists, nobody follows guidelines on drugs storage, properly leading to degradation of effectiveness of medicines and in many cases early expiry.
The Drugs and Cosmetics Act and the rules specify in detail parameters on premises, surroundings, sanitation, storage of raw materials, documentation and quality control systems among others that a manufacturer is required to comply with under the conditions of licence, a senior official said.
“The rules prescribe conditions to be satisfied before grant of licence for sale of drugs. These include adequate space, proper storage facilities for preserving the properties of drug.
“Storage of any drug under the recommended condition is important to ensure that they remain stable throughout their shelf life. If not stored properly, the drug may lose its efficacy and many lead to toxicity,” the official said.
Rule 65 under the Drugs and Cosmetics Act prescribes various conditions required to be followed by the licensee.
These include requirements of registered pharmacists for retail sale, prescription of registered medical practitioners for sale of prescription drugs by retail, maintaining records among others.
“Concerns have however been raised from time to time regarding bad storage conditions by the manufacturers, wholesalers and retailers. The Masheklar Committee recommended one inspector for 200 sales outlets and one inspector for 50 manufacturing units.”
“There are more than eight lakh sales outlets in the country and more than 1,000 manufacturing units. Accordingly, 4,200 drug inspectors are needed,” the official said.
As on April 2018, the total sanctioned strength of drug inspectors in the states and Union Territories is about 1,600, out of which about 1,200 drug inspectors are available. In CDSCO, as on January 2019, 224 drug inspectors are in position.
The issue has been deliberated multiple times in the meetings of Drugs Consultative Committee (DCC), a statutory body under the Act and drug controllers of all states and Union Territories are its members.
The DCC after detailed deliberation has finalised Good Distribution Practices guidelines to be followed by the manufacturers wholesalers and retailers to ensure that the drugs are stored under proper storage conditions throughout the supply chain.
The ‘good distributions practices’ contain guidelines regarding premises, warehousing and storage, temperature, environment and storage control transportation, shipment containers and labelling, dispatch and receipt, documentation complaints, recalls and returns, spurious pharmaceutical products, importation, contract activities and self-inspection, the official said.
These guidelines are applicable to all persons and outlets involved in any aspect of the storage and distribution of pharmaceutical products.